Practical Guide on Biocidal Products Regulation

Transcription

1 Practical Guide on Biocidal Products Regulation Special Series on -

2 2 Practical Guide on BPR: Special Series on LEGAL NOTICE This document aims to assist users in complying with their obligations under the Biocidal Products Regulation (BPR). However, users are reminded that the text of the BPR is the only authentic legal reference and that the information in this document does not constitute legal advice. Usage of the information remains under the sole responsibility of the user. The European Chemicals Agency does not accept any liability with regard to the use that may be made of the information contained in this document. Practical Guide on Biocidal Products Regulation: Special Series on - Reference: ECHA-15-B-04-EN Cat No.: ED EN-N ISBN-13: DOI: /43437 Publ.date: April 2015 Language: EN European Chemicals Agency, 2015 This document will be available in the following 23 languages: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovakian, Slovenian, Spanish and Swedish. If you have questions or comments in relation to this document please send them (indicating the document reference, issue date, chapter and/or page of the document which your comment refers) using the Information request form. The feedback form can be accessed via the Contact ECHA page at: European Chemicals Agency Mailing address: P.O. Box 400, FI Helsinki, Finland Visiting address: Annankatu 18, Helsinki, Finland

3 Practical Guide on BPR: Special Series on 3 DOCUMENT HISTORY Version Comment Date Version 1.0 First edition April 2015

4 4 Practical Guide on BPR: Special Series on PREFACE This Practical Guide on explains the practical aspects of data sharing obligations in the context of the Biocidal Products Regulation (EU) No 528/2012 (the BPR). It is part of a special series of practical guides on data sharing for the BPR, including also an Introduction to the BPR and SME considerations and Practical Guides on Letters of Access and Consortia. This Practical Guide should not be read in isolation. Other guidance documents are available from the Agency and reference to them is encouraged. The Special Series of Practical Guides has been developed by the European Commission in consultation with the European Chemicals Agency (the Agency ) and the Member State Competent Authorities (the MSCAs ), a sample of SMEs, representative associations, law firms and technical consultancies.

5 Practical Guide on BPR: Special Series on 5 Table of Contents LEGAL NOTICE 2 DOCUMENT HISTORY 3 PREFACE 4 LIST OF ABBREVIATIONS 6 LIST OF TERMS AND DEFINITIONS 7 1. WHAT IS THIS PRACTICAL GUIDE AND HOW WILL IT HELP? 9 2. THE DATA SHARING RULES: WHAT PRACTICAL STEPS THE PROSPECTIVE APPLICANT AND DATA OWNER SHOULD TAKE The Prospective Applicant The Data Owner/Data Submitter: suggested preparations in advance of approaches from Prospective Applicants Summary THE DATA SHARING RULES: THE TYPE OF NEGOTIATIONS THAT THE PARTIES MUST ENTER INTO AND THE WAY THAT COMPENSATION FOR DATA SHARING CAN BE CALCULATED Type of negotiation that can take place: Fast Track vs Standard Track Overall: the type of negotiations expected During the negotiations, the principles of compensation calculation General rules under Article 63 of the BPR: the typical costs basis balanced against typical increments/decrements Beyond compensation, other typical terms and conditions of data sharing THE POSSIBLE OUTCOMES OF THE NEGOTIATIONS Possible Outcome: The Negotiations are Successful Possible Outcome: The Negotiations are Unsuccessful 29 APPENDIX 1. TEMPLATE LETTER OF REQUEST TO DATA SUBMITTER /OWNER 32 APPENDIX 2. SUMMARY TABLE FOR DATA SHARING NEGOTIATIONS 33 APPENDIX 3. TEMPLATE NON-DISCLOSURE / CONFIDENTIALITY 34 APPENDIX 4. DATA SHARING CASE SCENARIO 37 APPENDIX 5. COMPENSATION CALCULATION FACTORS 40

6 6 Practical Guide on BPR: Special Series on List Of Abbreviations The following text conventions are used throughout the Practical Guide. Standard term / Abbreviation AH AS BPD BPF BPR EU LoA Explanation Authorisation holder Active substance Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (Biocidal Products Directive) Biocidal product family Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Biocidal Products Regulation) European Union Letter of access MSCAs Member State Competent Authorities responsible for the application of the BPR, designated under Article 81 of the BPR PT R4BP REACH SBP SMEs Product Type Register for Biocidal Products Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Same biocidal product Small and Medium Sized Enterprises

7 Practical Guide on BPR: Special Series on 7 List of Terms and Definitions For the purposes of the Practical Guides, the definitions in Article 3(1) of the Biocidal Products Regulation (EU) No 528/2012 (BPR) apply. The most relevant definitions are reproduced below, together with other standard terms used in the Practical Guides. Standard term / Abbreviation Access Agency Article 95 List Explanation The term is used to means the right to refer to data/studies when submitting applications under the BPR, further to an agreement reached with the data owner. Depending on the content of the data sharing agreement, it can also mean the right to inspect hard copies of studies and/or the right to obtain hard copies of studies. European Chemicals Agency, established under Article 75 of REACH The list of relevant substances and suppliers published by the Agency under Article 95(1) of the BPR Biocidal family Chemical similarity product A group of biocidal products having (i) similar uses; (ii) the same active substances; (iii) similar composition with specified variations and (iv) similar levels of risk and efficacy (Article 3(1)(s) BPR) A check which can be made prior to the adoption of the approval decision for an active substance, which assesses the substance identity and chemical composition of an active substance originating from one source with the aim of establishing its similarity regarding the chemical composition of the same substance originating from a different source. Data submitter Every effort The company/person which submits the data to the Agency/MSCA in connection with an application under the BPD or BPR The level of diligence required when negotiating the sharing of data according to Article 63(1) of the BPR Existing substance Fast track active A substance which was on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development (Article 3(1)(d) BPR) One method of obtaining an LoA for Article 95 purposes which envisages limited negotiations and a short written data sharing agreement. Also described as an "over-the- counter" transaction Letter of access an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of the BPR (Article 3(1)(t) BPR) New substance Prospective applicant active A substance which was not on the market on 14 May 2000 as an active substance of a biocidal product for purposes other than scientific or product and process-orientated research and development (Article 3(1)(d) BPR) Any person which intends to perform tests or studies for the purposes of the BPR (Article 62(1) BPR)

8 8 Practical Guide on BPR: Special Series on Standard term / Abbreviation Review Programme Related reference product Right to refer Explanation The work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Article 89 of the BPR In the context of an SBP authorisation, this is the biocidal product or product family which has already been authorised, or for which the application has been made, which the SBP is identical to Means the right to refer to data/studies when submitting applications under the BPR, further to an agreement reached with the data owner (the right is usually granted through an LoA). This right to refer can also be granted by the Agency following a data sharing dispute under Article 63(3) BPR. Same product biocidal A biocidal product/family which is identical to a related reference product/family, as per Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council Standard Track Technical Equivalence One method of obtaining an LoA which envisages detailed discussions on the rights covered by the LoA, together with a detailed written data sharing agreement Mean similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54 of the BPR (Article 3(1)(w) BPR). Technical equivalence is a requirement for a product authorisation application but is not a requirement for an application under Article 95 of the BPR and is not a legal pre-requisite for data sharing under Article 62 and Article 63 of the BPR

9 Practical Guide on BPR: Special Series on 9 1. What is this Practical Guide and how will it help? (a) (b) This Practical Guide provides practical guidance on one of the core issues that underpins the whole EU biocides regulatory system: data sharing. Specifically, it explains the following: What prospective applicants and data owners should do in practice to prepare themselves for data sharing; The way that negotiations should be conducted between parties; and The possible outcomes of the negotiations. The principal aim of this Practical Guide is to provide assistance to all parties involved in data sharing under the BPR so that they may come to data sharing agreements. The BPR places parties under an obligation to use every effort in good faith to reach an agreement on the sharing of data. If no agreement is reached, in certain circumstances for certain types of data, the Agency can help prospective applicants by granting permission to refer to the requested data. This Practical Guide provides tips and guidance on how parties can conduct their every effort negotiations successfully so that an agreement on a fair, transparent and nondiscriminatory sharing of data and their costs is reached. 2. The data sharing rules: what practical steps the prospective Applicant and Data Owner should take In this section, the following are addressed: For the prospective applicant, (a) what to do to identify the relevant data and (b) once identified, what happens next. For the data owner, suggested preparations in advance of potential approaches from prospective applicants The Prospective Applicant The BPR sets out the specific data that is required for the various processes. The following section sets out the steps an applicant can make to identify what data it needs, what data it is lacking and how to initiate negotiations. If a prospective applicant has no data, they may consider contacting directly the data owner/submitter and request the list of the data submitted and to which it would be interested to have access. This would be particularly relevant for companies seeking Article 95 listing, and may be interested to have the right to refer to the entire data set submitted by the participant in the review programme. (a) Identification of the data lacking Article 63(4) of the BPR states that the prospective applicant is only required to share the costs of information that it is required to submit for the purposes of the BPR. The starting point for any prospective applicant is therefore to ask oneself: what data am I lacking? both in terms of actual data missing and possibly improvements that could be made to the quality/robustness of the data that the prospective applicant has. As the right to refer to the data is granted on a per company/individual basis, in order to find the answer, prospective applicants will need to go through the following steps:

10 10 Practical Guide on BPR: Special Series on First Step: Identify the data requirements For dossier submissions under Articles 4 onwards of the BPR (approval of an active substance), the prospective applicant can identify all of the data that are expected in its dossier by reference to Annex II of the BPR and Annex III for at least one representative biocidal product. For dossier submissions under Article 20 onwards of the BPR (authorisation of biocidal products), the prospective applicant can identify all of the data that are expected in its dossier by reference to Annex III of the BPR and Annex II of the BPR for each active substance in the biocidal product. 1 For dossier submissions under Article 95 of the BPR (for inclusion on the Article 95 List), the prospective applicant can identify all of the data that are expected in its dossier by reference to Annex II to the BPR, or to Annexes IIA, IV or IIIA to the Biocidal Products Directive 98/8/EC (the BPD ). 2 For active substances which have already been approved, the information published by the Agency, in particular the assessment report (see Article 67 of the BPR), will also contain information on the data needed. Second Step: Establish the extent to which the data needs can be met by reference to data the prospective applicant already has or to which it can obtain ready and free access 3 In the following situations, the prospective applicant will not have to pay to share the required data: Where it already owns the data or has the right to use it for a BPR purpose. 4 Where the data endpoint concerned can be addressed with a data waiver or is not scientifically necessary. 5 Where the data that are lacking are no longer data protected under the applicable rules in the BPD/BPR. This is unlikely to be the case before 2017 as data protection periods under the BPD are, in the main, yet to expire. Furthermore, for existing active substances in the review programme (i.e. on the EU market on 14 May 2000 as an active substance of a biocidal product) where no decision on approval was taken before the entry into operation of the BPR, Article 95(5) of the BPR extends the protection period until 31 December Third Step: List the data that are lacking Compare and contrast the dossier data requirements with the data the prospective applicant already owns/has access to. 1 Note that less data is required for an application for simplified authorisation, as set out in Article 20(1)(b) of the BPR. 2 On this, see also the Agency s Guidance on Article 95 of the BPR: 3 See page 84 of the REACH Guidance at section Step 1: Individual Gathering and Inventory of Available Information for guidance and information on the equivalent REACH rules. See also pages which give guidance in particular on issues relating to copyright and the extent of the rights of parties to refer to published data and/or to data whose intellectual property is owned by a third party. 4 The prospective applicant might not own the data but nevertheless has reached an agreement with the data owner that it can use the data for BPR purposes. The concept of using the data will depend on the agreement with the data owner and could include a letter of access granting a right to refer to that data or the right to physically access to the actual studies and the right to submit those studies or a letter of access. 5 See Article 6(2) and Article 21 of the BPR for further details.

11 Practical Guide on BPR: Special Series on 11 Fourth Step: Identify whether or not they are vertebrate animal data Identifying whether or not a given test involves testing on vertebrate animals should not be difficult. If the test involves vertebrates, the prospective applicant is not allowed to repeat the study if the same study has been submitted already under the BPD/BPR. To find out if tests have been submitted, the prospective applicant can submit an inquiry to the Agency. For any data sharing negotiations, both parties will need to make every effort to reach an agreement. If negotiations fail, the Agency can grant permission to refer to vertebrate data (for further details see section 4.2). Fifth Step: If the dossier submission is being made under Article 95 of the BPR the prospective applicant should be aware that in the event of unsuccessful negotiations, the Agency can also grant permission to refer to toxicological, ecotoxicological and environmental fate and behaviour studies relating to an existing active substance included in the review programme (for further details see section 4). Conclusion on Identification of the Relevant Data At the end of these steps, the prospective applicant will have identified exactly what vertebrate animal data it is missing and, if inclusion on the Article 95 List is being sought, what existing active substance toxicological, ecotoxicological and environmental fate and behaviour studies it is missing. The prospective applicant will also have established if any non-vertebrate animal data are missing. In any case, the parties to the negotiations the prospective applicant and the data owner must abide by the data sharing rules when an approach is made by the prospective applicant to the data owner the principal one being that every effort must be used in those negotiations (for further details see section 3.2). (b) Once the prospective applicant establishes that it is missing relevant data, what happens next? This Practical Guide places an emphasis on the prospective applicant s and data owner s right to contract freely between themselves. The starting point for data sharing therefore lies outside the BPR and in the hands of those two sets of parties. If the prospective applicant and data owner come to a voluntary data sharing agreement, there is no reason to have recourse to the BPR s inquiry or dispute procedures. That may happen if, for example, the prospective applicant already knows what company/person owns the data it is looking to share in that situation, it can simply choose to approach that company/person with a view to negotiating access without involving the Agency at all. And it may happen with regard to both complete dossiers of data, to cherry-picked studies and to any kind of study required. In short, anything can be negotiated between the relevant parties with regard to data sharing under the BPR in the knowledge that the dispute procedure only exists in certain circumstances (for further details see section 4.2). If the prospective applicant does not know who the data owner is, or whether the data it is looking for has already been submitted to the Agency/MSCAs, it can inquire with the Agency. Note that a dispute claim can be made at the earliest one month after an inquiry has been answered by the Agency. Those rules are found in Articles 62 and 63 of the BPR and, under them, there are three principal steps to take.

12 12 Practical Guide on BPR: Special Series on FIRST: Consider whether to submit an Inquiry to the Agency 6 What the law says What to do in practice Article 62(2) of the BPR states that prospective applicants (i.e. persons intending to perform tests or studies ) shall, in the case of vertebrate data, and may, in the case of other data, submit a written request to the Agency to determine whether such tests or studies have already been submitted to the Agency or to a MSCA in connection with a previous application under the BPR or BPD. To submit a request, register and log onto R4BP. o Go to: o 7 o Click on link to R4BP on the right hand side of that page. o Fill in the registration form there if not already done. Click on the required application type (see for more information) Complete the relevant section by using the drop down menu to identify the active substance you are interested in. The Agency checks to see if data have already been submitted for that substance. SECOND: The Agency's Reply What the law says Article 62(2) of the BPR states that, on receipt of a request, the Agency will establish whether the studies identified have already been submitted to it or to an MSCA. If it does identify that the data have already been submitted to it or to an MSCA, it will without delay, communicate the name and contact details of the data submitter and data owner to the prospective applicant. What to do in practice If data have already been submitted to the Agency or to an MSCA for the purposes of the BPR or BPD, the Agency will notify the prospective applicant. The Agency will normally respond within 15 working days of the request being sent to it by the prospective applicant. The name and contact details ( address) of the company/person which submitted the data to the Agency/MSCA (the data submitter ) will be communicated to the prospective applicant. The prospective applicant will also be given an asset number which must be retained as that will allow it to prove that it made the inquiry if matters proceed to a dispute. Note also that the Agency will not only notify the prospective applicant of these details but will also inform the data submitter that it has received a written request from a prospective applicant. 6 See page 78 of the REACH Guidance at section 4.1 The Purpose of the Inquiry Process and section 4.2 Is it obligatory to follow the inquiry process? for guidance and information on the equivalent REACH scenarios. 7 See also Biocides Submission Manual Version 3.0 section 7.1:

13 Practical Guide on BPR: Special Series on 13 THIRD: Request of the Data Owner What the law says Article 62(2) of the BPR says that the data submitter shall, where relevant, facilitate contacts between the prospective applicant and the data owner. Article 63(1) of the BPR says that, where a request to share data has been made, the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested ( ) Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order. What to do in practice Once the prospective applicant receives the contact details of the data submitter from the Agency, it is up to it to send a request to the data submitter. A list of submitted individual tests or studies should be requested from the data submitter (see next step). 8 At this point, it is for the data submitter to assist with facilitating contact with the data owner where relevant. Both parties (prospective applicant and data submitter/owner) are under an obligation to use every effort to reach an agreement on sharing the data that have been identified. Accordingly, plan ahead. A template letter of request is provided at Appendix The Data Owner/Data Submitter: suggested preparations in advance of approaches from Prospective Applicants (a) (b) Any company/person that owns data which have been submitted for any purpose either to an MSCA or to the Agency under the BPD/BPR is potentially going to receive a request for data sharing. It should also be anticipated by data owners that requests for access to individual studies (vertebrate and non-vertebrate) will be received as well as possible requests for access to complete dossiers. Accordingly, although there is no legal requirement to do this under the BPR, what data owners may consider doing is completing the following two steps in order to avoid delays in the data sharing negotiation process. First: Establish if an approach from a prospective applicant is likely Review, as far as possible, the activities the data submitter/owner has undertaken to date under the BPD and/or the BPR. That review should look to identify the occasions on which its data, whether owned jointly or individually, have been submitted to any of the MSCAs in the EU or to the Agency. Include all of these. Either way, the fact that the relevant regulatory authorities will have recorded the data submitter s name in relation to the test/study means that there is the potential for it to be contacted by a prospective applicant. An approach is therefore likely if: The data relate to an active substance in the review programme. 8 If however, the prospective applicant cannot obtain this information from the data submitter, this may be an indication that the data owner is not making every effort. When negotiating data and cost sharing, note also that the prospective applicant is not necessarily required to have access to all submitted data, but only to the data required to submit for the purpose under the BPR.

14 14 Practical Guide on BPR: Special Series on The data relate to a new active substance which was approved or is being evaluated under the BPD or BPR. The data relate to a biocidal product which is being evaluated or has been authorised under the BPD or BPR. In the context of Article 95 of the BPR, participants in the review programme are likely to be approached by a prospective applicant and should therefore consider preparing accordingly. Timing-wise, that potential is increased in particular by the 1 September 2015 deadline contained in Article 95. However, note that any person/company which submitted data or owns data that has been submitted may be contacted by a prospective applicant to negotiate data sharing. Second: Prepare accordingly If data have been identified, consider doing the following: Make a detailed list of the data/studies/tests submitted and be prepared to share this list in case you are contacted by a prospective applicant interested in data sharing. Note the CAS and EC numbers of the substance concerned. Note the specifics of the study (date, author, type, etc) Collect information on study costs. Outline an internal set of procedures to deal with any approach that is received. Appoint members of staff to be responsible for dealing with such approaches. If the data are owned with others, coordinate as far as possible in advance with them on who will take the lead or share the lead in responding to an approach and how that will be undertaken. Consider the role of the data submitter if that is a company/person different from the data owner. In particular: o o o o Check to see if the data submitter has a mandate to negotiate on the data owner s behalf; Check to see if the data submitter has a mandate to negotiate access to a range of data (e.g. the complete dossier) so that negotiations do not necessarily have to take place on a study-by-study basis; Check to see if the data submitter has a mandate to negotiate access with a group of prospective applicants; and In general, coordinate with the data submitter on the approach to data sharing that needs to be adopted. Again, especially in the context of the upcoming deadline relating to Article 95 of the BPR, and in light of the obligation to make every effort to agree on sharing data, such information, in particular the list of studies, should be readily provided by the data submitters/owners upon request when prospective applicants make contact. In addition, as described below, data owners might also consider the option of a fast track route and to have developed possible scenarios to facilitate an agreement through a simplified negotiation Summary (a) The steps mentioned above are suggestions only with the aim of facilitating negotiations to share data between the prospective applicant and the data owner (or data submitter). The steps are neither prescriptive nor mandatory.

15 Practical Guide on BPR: Special Series on 15 (b) (c) The key principle to bear in mind at all times is that any and all types of data can be shared under the BPR. The data can be vertebrate or non-vertebrate, they can be a single study or a complete dossier. It is up to the parties to agree what they wish to share, in the knowledge that under certain circumstances data sharing can be forced by the Agency for vertebrate animal data and for toxicological, ecotoxicological, environmental fate and behaviour data relating to the inclusion on the Article 95 List for an existing active substance in the review programme. The negotiations may relate to obtaining the right to refer to the studies only in the form of an LoA, or also to obtain access to hard copies or actual copies of the data, and the right to use that data (either submitting copies or a letter of access). The parties are free to negotiate; however, the prospective applicant cannot be forced to buy more than the simple right to refer, while in turn the data owner cannot be forced to sell more than the simple right to refer. Regardless of the type or extent of data access sought, the same principles of negotiation will apply: each party must approach those negotiations using every effort to reach a data sharing agreement that is fair, transparent and nondiscriminatory. The next section explains what that entails. 3. The data sharing rules: the type of negotiations that the parties must enter into and the way that compensation for data sharing can be calculated 9 As this Practical Guide aims in particular at facilitating the data sharing process, it is designed to assist parties successfully to reach an agreement and avoid disputes. Indeed, involving the Agency to establish whether the prospective applicant and the data owner have used every effort (perhaps after a long period of negotiation) should be a last resort where negotiations have failed. With that in mind then, the Practical Guide below provides: an explanation of the type of negotiation that can take place; and a step-by-step approach to data sharing to show which factors are involved in an every effort negotiation and how the cost contribution can be determined in a fair, transparent and non-discriminatory manner Type of negotiation that can take place: Fast Track vs Standard Track The BPR does not prescribe what kind of negotiations should take place but this Practical Guide suggests two approaches: the first is the fast track ; the second is the standard track. Before explaining the difference, regardless of the type of negotiations that are entered into between parties, the BPR requires (i) that every effort is used by the parties, and (ii) that the cost is determined in a fair, transparent and non-discriminatory manner. One clear message to take away is that these principles apply at all times whether or not it is a fast track or standard track negotiation that is followed. The First Route: Fast-Track It may be that prospective applicants and data owners will not wish to enter into negotiations beyond what is absolutely necessary to sell and buy a letter of access (an 9 See also page 18 of the REACH guidance at section 1.3 Key Principles for and page 93 at section How to conduct negotiations in order to prevent data sharing disputes? for more information and guidance in equivalent REACH scenarios.

16 16 Practical Guide on BPR: Special Series on LoA ). It may be that they are satisfied that they can agree to share data without complex contractual arrangements. There is, after all, nothing under the BPR itself that requires the parties to enter into lengthy and detailed negotiations to consider all the possible ins and outs of data sharing, and there is nothing that requires the parties to enter into non-disclosure or written data sharing agreements. Such fast track negotiations may be appropriate in certain circumstances, for example where the negotiations are necessarily subject to a tight regulatory timeframe such as the 1 September 2015 deadline for listing on the Article 95 List. It may also be that the subject-matter of data sharing lends itself to an over-the-counter type negotiation because, in reality, the transaction is a simple one. That could be the case, for example, for certain commodity-type chemicals and simple data/dossiers, and especially when an LoA to the complete dossier is sought and offered. The fast track route is designed to cater for the over-the-counter scenario. It may be that parties believe it is appropriate where (one or more of) the following factors are present: The prospective applicant is seeking a right to refer to the studies only, and not access to hard copies or actual copies of the data, for instance. The prospective applicant wants to be included on the Article 95 List. The prospective applicant is seeking a right to refer to a complete substance dossier which the data owner is willing to sell. The complete substance dossier is likely to be of interest to many prospective applicants 10 and/or those applicants are each seeking a right to refer to the data for the same purpose. The costs of the dossier are easy to identify. The costs can be relatively easily calculated and applied equally (i.e. in the same amount) across all potential prospective applicants. The data owner can show that the cost calculation has been made fairly and in a non-discriminatory fashion. The data owner is transparent about how that calculation was made and on which cost items it is based. It may also be that the fast track is appropriate even where the parties agree to certain restrictions to the scope of the LoA. Such restrictions could include the following, for example: The prospective applicant is seeking a right to refer to support biocidal products in just one or more Member States and the parties agree that the data compensation is reduced pro rata on the application of objective criteria. The prospective applicant is seeking a right to refer to support biocidal products for a specific application or, for instance, it is not interested in consequential rights under Article 95(4) of the BPR and the parties agree that the data compensation necessitate decrements to the costs. If the parties agree that a fast track procedure is appropriate to grant the right to refer to the data, the parties may consider using the template LoA in the Practical Guide on Letters of Access. It is designed to be downloaded, and signed by both parties. It can be accompanied by a simple set of terms of conditions, e.g. to reflect the understanding reached between the parties as to the scope of the LoA or as to payment terms (instalments, refund mechanism, etc.). While a refund mechanism or the upfront discount for the renouncement to a future 10 This may, for example, be the case with commodity substances, where a large number of prospective applicants each seeks to be included on the Article 95 List as suppliers for the commodity substances they use in their biocidal products.

17 Practical Guide on BPR: Special Series on 17 refund might require some discussions between the parties, also such agreements can be accommodated in the fast track procedure. Similarly, the parties may also agree that the prospective applicant will contribute to the costs of potential additional studies that may be required to be undertaken by the data owner/submitter (for example in the review programme for existing active substances). It is of course for each party to agree voluntarily that the fast track procedure and simplified LoA/terms and conditions is appropriate for it. In order to assist with that decision, it is incumbent on the data owner to demonstrate that the cost calculation has been determined in a fair, transparent and non-discriminatory manner before the LoA is signed. The Second Route: The Standard Track The standard route LoA is proposed in any other situation other than described above under the fast-track route. In particular, the standard route would be more appropriate where the parties want to negotiate a tailor-made data sharing arrangement. That may be the case where, for example: The costs of the data to which access is being sought are complex (perhaps, for example, because of historical reasons or exceptionally high fees in the review programme for existing active substances). The prospective applicant wishes to review the studies or wants to negotiate additional special rights e.g. for uses other than under the BPR. Where the parties raise an issue which requires a degree of negotiation before an agreement can be reached, the standard track route could be an option. Prior to entering into such standard track negotiations, the parties may choose to enter into a nondisclosure agreement. 11 A written data sharing agreement will also normally result from standard track negotiations. In that regard, the template non-disclosure agreement at Annex 3 may be of assistance Overall: the type of negotiations expected As noted, the core principle underpinning the data sharing rules is found in Article 63(1) of the BPR which requires both parties the prospective applicant and the data owner to make every effort to reach an agreement on the sharing of the results of the tests or studies that have been requested. Article 63(4) of the BPR reinforces the requirement for every effort to be used during the negotiation process by stating that compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner. The obligation to use every effort during the negotiations falls to both the prospective applicant and the data owner it is not a one-way obligation. In practice, in case of a dispute, the Agency will assess whether every effort has been made since the entry into force of the BPR on 1 September But what does every effort mean? The BPR provides no legal definition. The Agency will provide more concrete guidance in the form of its decisions. A link to the Agency decisions taken to date can be found at 11 When confidential information is being exchanged between the parties, a non-disclosure agreement may become appropriate. Such information could include active substance profile, list of customers, names of Member States for which a product authorisation is sought, exact product type, etc. However, note that the actual elements for the costs calculation are not confidential information in the sense of being commercially sensitive; to the contrary, a cost breakdown needs to be provided by the data owner without requiring that a non-disclosure agreement be signed. Importantly, any non-disclosure agreement should not prevent the parties from disclosing information to the authorities, in particular the Agency in the dispute procedure under Article 63 of the BPR or infringe the principle of non-discrimination as regards eventual agreed costs.

18 18 Practical Guide on BPR: Special Series on regulation/data-sharing/echa-decisions-on-data-sharing-disputes-under-bpr. 12 Also, decisions of the Board of Appeal 13 will be relevant. In the absence of a strict definition, the principal rule to follow is that each party is free to contract with the other party as it sees fit, subject to the requirements of the BPR. Whether every effort has been used by each party in the negotiations will be assessed by the Agency in the context of each individual case. That said, the guidance below helps parties with ideas on what they can do to reach an agreement. Act in time Both parties must fulfil their data sharing obligations in a timely manner. They are encouraged to allow a reasonable time for the negotiations and to initiate efforts early. In case a dispute is lodged, the Agency will assess the every effort obligation on a case by case basis; there is no minimum or maximum time for negotiations. They should be aware of all the regulatory timing that is applicable. They should also be aware of any (reasonable) timeframes that are set by the other party. In that regard, and by way of example, if one party wishes to give the other a specific deadline by which it is to answer a question, it should come up with a timeframe that it itself would consider to be reasonable. Reasonable should take into account the situation of the other party, for example: If the other party is an SME, it may be under resource constraints and struggle to attribute time and human resources to the negotiations, or If the other party is a task force or consortium then bear in mind that decisionmaking may be slower, both because the decision has to be taken by more than one company/person and because it may be making or be in receipt of multiple requests for data sharing. All in all, parties should treat each other as they would themselves. In setting deadlines, it would also assist to be as precise as possible that will avoid confusion and ambiguity and should lead to smoother negotiations. By doing that, and should the negotiations be unsuccessful, the Agency will see whether clear and fair deadlines were given. And if the deadline is missed, follow up and ask why that was the case. Keep records of all negotiations Carefully record every substantive and relevant communication with the other party. Every phone call or meeting that takes place should be followed by a note of what was discussed; that note should be shared with the other party (as in case of a potential dispute the Agency will only consider documents that have been exchanged between the parties), and with a request that it expressly agrees to its contents by ; makes changes to it; or be deemed to have accepted its contents as an accurate reflection of the meeting if it does nothing within a reasonable period of time (again, it would probably be better to pinpoint an exact time as opposed to stating a period of time to elapse). It would help if every substantive phone call or other verbal communication is converted into a contemporaneous written document (meaning, convert it within, for example, a day of the communication happening); it should then follow the same exchange and approval process as above. 12 Decisions taken by the Agency in the context of the REACH Regulation are also useful points of reference: 13 See

19 Practical Guide on BPR: Special Series on 19 It would assist if any substantive sent to the data owner and vice-versa had a read receipt. Every substantive should be saved and kept in a safe place, as both prospective applicant and data owner might need to provide the Agency with such documentation in case a dispute is lodged. Be open, honest and realistic Do not hide essential negotiation points until the last moment; avoid ambushes. Indicate up front if certain treatment is being sought because, for example, of the prospective applicant s or data owner s SME status; do not be afraid to admit to lack of resources or experience or capabilities; and do so in the knowledge that the other side is encouraged to take this specifically into account. If face-to-face meetings are to be arranged, be sensitive to the fact that the other party may live in a part of the EU that is distant, and with which there are no direct transport links, etc; in other words, be reasonable and flexible in the expectation of how the negotiations will be conducted consider or other forms of communication instead. Be consistent and reliable. Consider following these recommendations Make sure that every reasonable overture from the other party is replied to in a timely fashion. Make sure to give the other party a reasonable amount of time to react (weekends and holidays should not be counted in the timing). If you consider that the other party is delaying the negotiations, explain the reasons for urgency. Be sure to challenge the other party if they are slow in replying; ask them to speed up or provide reasons for their delay and comment appropriately (and politely). If there are no reasonable excuses being provided, document them and then issue the other party with a warning. Document that warning. Where a party receives an unsatisfactory reply, which it considers unclear, invalid or incomplete, it is the responsibility of the recipient to challenge that reply by addressing constructive, clear questions or arguments to the other party. Be sure to explain clearly what the specific data requests are; leave no room for ambiguity. Conclusion on Every Effort When trying to determine whether every effort has been made, consider using a third party (not necessarily a lawyer or consultant, just someone who is not one of the parties involved) and use common sense when going through the evidence that may demonstrate every effort on your part. Be very clear that the every effort obligation applies to all parties taking part in the negotiations. There is a reasonable expectation that where parties operate the rules with goodwill and in good faith, they will come to an agreement. However, if negotiations fail, as a last resort the prospective applicant can request help from the Agency by lodging a dispute claim. Both parties should reflect on the fact that the system has been designed to be relatively straightforward. There are no fees to be paid to the Agency, for example, and no lawyers need to be involved. Initially it will be for the prospective applicant under the dispute procedure to demonstrate to the Agency that it has adhered to this requirement. As mentioned before, the data owner will also be invited to submit its evidence proving that every effort was made, and the Agency s assessment of efforts made will be based on the documentation provided by

20 20 Practical Guide on BPR: Special Series on both parties. If the prospective applicant has made every effort while the data owner has failed to do so, the Agency will grant the prospective applicant permission to refer to the requested data. The outcome of a dispute procedure will not satisfy either party in the same way that a mutually acceptable arrangement would. The dispute process should only be triggered if such a voluntary agreement cannot be reached. In that regard, parties should also bear in mind that the Agency will only look at the efforts made before the dispute was submitted. So take an appropriate amount of time to see through the negotiations before informing the Agency that an agreement could not be reached. Also note that a voluntary agreement can still be found after a dispute claim has been lodged with the Agency, and even after the Agency has issued its decision. Therefore, be open for discussions also during an ongoing dispute procedure. NOTE to the reader: See Appendix 2 for a take-away tips document 3.3. During the negotiations, the principles of compensation calculation 14 (a) (b) The expectation is that all parties approach negotiations in good faith: the prospective applicant will gain access to the data it needs while the data owner will receive equitable compensation. Data sharing negotiations, therefore, must not be viewed as a commercial opportunity but recognition of the fact that the efforts spent by the data owner in generating the data must be reasonably and fairly compensated by those who are now required to rely on them. It allows prospective applicants to afford access to required data which they would not be able to finance if they were to bear the entire costs on their own. This is of assistance in particular to SMEs. That is underlined by what the law says. Article 63(4) of the BPR states that compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner. So what does that mean? Transparency While the concepts of fairness, transparency and non-discrimination have each to be met individually, if the negotiations are conducted transparently, it will become clear whether or not the parties are acting in a fair and non-discriminatory manner. Transparency includes the obligation for the data owner to provide details on the individual cost items, and the way that it has calculated its costs and applied its principles. Such information, including e.g. a cost breakdown or basic information on the calculation methods, should be disclosed by the data owner upon request. Any hesitation that such transparency may mean having to reveal confidential calculations, for example, might be balanced out by asking the prospective applicant to sign a non-disclosure agreement. Such an agreement is not a requirement under the BPR, or the law in general, but where negotiations touch on commercially sensitive issues (such as the territories in which the prospective applicant wishes to sell the relevant product), a non-disclosure agreement might be considered. In any event, for as long as it does not prevent the cost calculation from being determined in a fair and non-discriminatory manner, it should not compromise the transparency of the process. A template for such a non-disclosure/confidentiality agreement (an NDA ) is found at Appendix See page 87 of the REACH Guidance at section Step 5: Negotiation on Data and Cost Sharing, and Possible Outcomes for guidance and information on the equivalent REACH rules.